Anixa Biosciences Announces Notice of Allowance of Additional Key Patent on Breast Cancer Vaccine Technology

On February 27, 2023 Anixa Biosciences, Inc. (NASDAQ: ANIX) ("Anixa"), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the U.S. Patent and Trademark Office (USPTO) has issued a Notice of Allowance broadening protection of Anixa’s novel breast cancer vaccine technology (Press release, Anixa Biosciences, FEB 27, 2023, View Source [SID1234627713]). This technology was invented and developed at Cleveland Clinic and Anixa is the exclusive worldwide licensee.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The patent is titled, "Vaccine Adjuvants and Formulations," and the lead inventor is the late Dr. Vincent Tuohy, of Cleveland Clinic. This patent covers additional intellectual property related to the formulation of Anixa’s breast cancer vaccine.

"We are pleased to receive this notice of allowance from the USPTO, confirming additional protection of our breast cancer vaccine technology," stated Dr. Amit Kumar, Chairman and CEO of Anixa. "This breast cancer vaccine has the potential to prevent Triple Negative Breast Cancer ("TNBC"), the deadliest form of breast cancer, and perhaps other forms of breast cancer that express alpha-lactalbumin. With our partners at Cleveland Clinic, we are currently performing clinical trials of this vaccine, and plan to present data from the trial at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in April."

About Triple-Negative Breast Cancer
One in eight women in the U.S. will be diagnosed with an invasive breast cancer at some point in their lives. Approximately 10-15% of those diagnoses are TNBC, however TNBC accounts for a disproportionately higher percentage of breast cancer deaths and has a higher rate of recurrence. This form of breast cancer is twice as likely to occur in African-American women, and approximately 70% to 80% of the breast tumors that occur in women with mutations in the BRCA1 genes are triple-negative breast cancer.

About Anixa Bioscience’s Breast Cancer Vaccine
Anixa’s breast cancer vaccine, currently in Phase 1 trials, takes advantage of endogenously produced proteins that have a function at certain times in life, but then become "retired" and disappear from the body. One such protein is a breast-specific lactation protein, α-lactalbumin, which is no longer found post-lactation in normal, aging tissues, but is present in the majority of triple-negative breast cancers. Activating the immune system against this "retired" protein provides preemptive immune protection against emerging breast tumors that express α-lactalbumin. The vaccine also contains an adjuvant that activates an innate immune response, which allows the immune system to mount a response against emerging tumors to prevent them from growing. This vaccine technology was invented by the late Dr. Vincent Tuohy, who was the Mort and Iris November Distinguished Chair in Innovative Breast Cancer Research in the Department of Inflammation and Immunity at Cleveland Clinic’s Lerner Research Institute. Dr. Tuohy is named as inventor on the technology, which Cleveland Clinic exclusively licensed to Anixa Biosciences.

Chinook Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Updates

On February 27, 2023 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the fourth quarter and year ended December 31, 2022 and provided corporate updates (Press release, Chinook Therapeutics, FEB 27, 2023, View Source [SID1234627712]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"During 2022, we made excellent progress across our pipeline, including driving strong enrollment of our phase 3 ALIGN, phase 2 AFFINITY and phase 1/2 BION-1301 clinical trials, generating compelling clinical data from our atrasentan and BION-1301 programs for IgA nephropathy (IgAN), initiating our phase 1 clinical trial of CHK-336 in healthy volunteers and continuing to advance our preclinical programs for rare, severe chronic kidney diseases," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "Our mission at Chinook is to change the course of kidney care by developing therapies that make dialysis and transplant unnecessary for patients living with kidney disease. With our strong financial position and growing team, we look forward to an exciting 2023 when we will be presenting data from all three of our clinical programs at medical conferences, commencing a phase 3 study of BION-1301 in patients with IgAN mid-year and reporting topline proteinuria data from the ongoing phase 3 ALIGN study of atrasentan."

2022 and Recent Accomplishments

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has potential therapeutic benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial is evaluating atrasentan in patients with IgAN and the phase 2 AFFINITY basket trial is evaluating atrasentan in patients with proteinuric glomerular diseases.

Enrollment in the phase 3 ALIGN trial of atrasentan now exceeds 270 patients. The interim proteinuria endpoint analysis will be performed on the first 270 patients enrolled.

In response to review of the statistical analysis plan for the ALIGN trial, Chinook received correspondence from the U.S. Food and Drug Administration (FDA) last week recommending that evaluation of the interim proteinuria endpoint analysis for accelerated approval in the ALIGN trial be delayed from week 24 to week 36. The FDA referenced the likelihood that the later timepoint would allow for a greater amount of eGFR data to be evaluated at the time of accelerated approval. Chinook plans to engage with the FDA as soon as possible to discuss their advice. If Chinook shifts the interim proteinuria endpoint analysis of the ALIGN trial to 36 weeks, topline proteinuria data would be expected in the fourth quarter of 2023. Therefore, Chinook is updating its timing to report topline proteinuria data from the ALIGN trial to the second half of 2023.

Chinook has completed enrollment of the IgAN patient cohort of the AFFINITY trial, and continues to enroll the other cohorts, including patients with focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors. Chinook plans to report additional data from cohorts of the AFFINITY trial in the second half of 2023.

In November 2022, the United States Patent and Trademark Office (USPTO) issued U.S. Patent No. 11,491,137, titled, "Methods of Improving Renal Function," which is directed to methods of treating patients with IgAN with atrasentan, and expires in 2040 absent any patent term extensions.

Several presentations on atrasentan were delivered at nephrology conferences throughout 2022, including:

Updated interim data from the IgAN patient cohort of the phase 2 AFFINITY trial demonstrated consistent and clinically meaningful proteinuria reductions in patients with IgAN already on a maximally tolerated and stable dose of a RAS inhibitor. Specifically, atrasentan demonstrated mean reductions in 24-hour urine protein creatinine ratio (UPCR) of 38.1% at six weeks of treatment, 48.3% at 12 weeks of treatment and 54.7% at 24 weeks of treatment. After 24 weeks of treatment, 15 of the 19 patients (79%) who had completed this visit had greater than a 40% reduction in UPCR. There were no meaningful changes in blood pressure or acute eGFR effects, suggesting proteinuria reductions were not primarily due to hemodynamic effects of atrasentan, and there were no increases in BNP or mean bodyweight, suggesting minimal fluid retention. Atrasentan was well-tolerated, with no treatment-related serious adverse events. (ASN Kidney Week 2022)

Preclinical research on single-cell RNA-seq of a mouse model of IgAN, revealing a prominent expansion of failed repair proximal tubular epithelial cells, which was reversed by atrasentan but not by ACE inhibition. (ASN Kidney Week 2022)

Preclinical mechanistic data describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system. (59th ERA Congress)

BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) has been demonstrated clinically in both healthy volunteers and patients with IgAN.

Chinook has finalized trial design, is conducting site and country feasibility and completing global regulatory interactions to enable initiation of a phase 3 trial of BION-1301 in mid-2023.

Chinook has completed enrollment of 30 patients in Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301. Patients in Cohort 2 receive a subcutaneous (SC) dose of 600 mg of BION-1301 every two weeks. Chinook plans to report additional data from Cohorts 1 and 2 in the first and second half of 2023.

Chinook presented interim data from Cohorts 1 and 2 in a poster presentation at ASN Kidney Week 2022 in November, further demonstrating BION-1301’s disease-modifying potential in IgAN by generating rapid and durable reductions in mechanistic biomarkers and corresponding clinically meaningful proteinuria reductions within three months of initiating treatment, which was consistent across both cohorts.

In Cohort 1, patients transitioned from intravenous (IV) dosing at 450 mg every two weeks to SC dosing at 600 mg every two weeks after at least 24 weeks of treatment. Reductions in IgA and Gd-IgA1 were maintained beyond 52 weeks of treatment. Reductions in IgM, and to a lesser extent IgG, were also observed. BION-1301 demonstrated mean reductions in 24-hour UPCR of 30.4% in seven patients at 12 weeks of treatment, 48.8% in eight patients at 24 weeks of treatment, 66.9% in eight patients at 52 weeks of treatment, 67.4% in four patients at 76 weeks of treatment and 71.0% in two patients at 100 weeks of treatment.

In Cohort 2, SC BION-1301 treatment resulted in rapid and sustained reductions in IgA and Gd-IgA1, IgM, and to a lesser extent IgG, through 24 weeks of treatment, highly consistent with Cohort 1. BION-1301 demonstrated mean reductions in 24-hour UPCR of 28.7% in 15 patients at 12 weeks of treatment and 53.8% in 9 patients at 24 weeks of treatment, similar to reductions observed at the same timepoints in Cohort 1.

In both cohorts, BION-1301 was well-tolerated, with no serious adverse events or treatment discontinuations due to adverse events, and no anti-drug antibodies observed.

BION-1301 was granted orphan drug designation for the treatment of primary IgAN by the European Commission in July 2022.

CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH) and other kidney stone disorders driven by endogenous overproduction of oxalate.

The phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) clinical trial evaluating CHK-336 in healthy volunteers is ongoing, and initial data from this trial is expected in the first half of 2023.

Chinook presented a poster on CHK-336 at ASN Kidney Week 2022, demonstrating preclinical efficacy in PH1 and PH2 mouse models, and the potential for benefit in non-genetic hyperoxalurias caused by oxalate overproduction was also described.

Precision Medicine Research & Discovery
Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths. Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates. Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.

Chinook delivered an oral presentation at ASN Kidney Week 2022 in November on a multi-omics approach to the characterization of IgAN in the NURTuRE cohort, integrating clinical, histological, transcriptomic and serum proteomic data to gain deeper insights into patient stratification and IgAN disease pathogenesis. Also at ASN, Chinook presented a poster in collaboration with Evotec on a human data-driven, patient-centric and multi-omics-enabled target identification framework focused on common cellular and molecular mechanisms of CKD by leveraging the NURTuRE and QUOD patient cohorts.

Chinook delivered an oral presentation at the 59th ERA Congress in May 2022 on the approach used in collaboration with Evotec to leverage the NURTuRE CKD biobank to generate mechanistic disease understanding for patient-centric, integrated target and biomarker discovery that will enable the development of novel precision treatments for CKD patient subsets.

Corporate

Chinook recently announced the appointment of Andrew Oxtoby as Chief Commercial Officer. Under Andrew’s leadership, Chinook will develop its go-to-market strategy and build a commercial organization in preparation

for the potential launch of atrasentan and future pipeline products. Andrew brings to Chinook over 20 years of experience in marketing, sales, finance and commercial leadership roles at Aimmune Therapeutics and Eli Lilly and Company.

Sairopa B.V. (Sairopa) entered into an exclusive agreement with Exelixis, Inc. in November 2022 for the development of ADU-1805, a monoclonal antibody targeting SIRPα, and received an upfront payment of $40.0 million. The U.S. Food and Drug Administration (FDA) recently cleared Sairopa’s Investigational New Drug (IND) Application to evaluate the safety and pharmacokinetics of ADU-1805 in adults with advanced solid tumors, which triggers a $35.0 million milestone payment that will be paid to Sairopa in the first quarter of 2023. Under the terms of the agreement, Sairopa is eligible to receive additional payments if Exelixis exercises its option and upon achievement of specified development, commercial and net sales milestones, as well as tiered royalties on net sales worldwide. As of December 31, 2022, Chinook owned approximately a 36% interest in Sairopa and has one seat on its board of directors. Chinook will hold its shares in Sairopa until there is a liquidation event, at which time, in accordance with the CVR agreement, 50% of any net proceeds will accrue to the benefit of the CVR holders, net of deductions permitted, including taxes and certain other expenses.

Chinook closed a $120.7 million public offering in May 2022, which included the exercise in full of the underwriters’ option to purchase additional shares of common stock.

Chinook announced an outreach initiative in collaboration with the IgA Nephropathy Foundation and Komodo Health in April 2022, leveraging data and technology to drive awareness of IgAN and engage key medical providers at nephrology practices across the U.S., with the goal of ensuring patients have access to optimal support and treatment options earlier in their disease journey.

Fourth Quarter and Full Year Ended December 31, 2022 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $385.3 million as of December 31, 2022, compared to $355.1 million as of December 31, 2021.

Revenue – Revenue for the quarter and year ended December 31, 2022 was $0.5 million and $6.1 million, respectively, compared to $51.2 million and $51.6 million for the same periods in 2021. The higher revenue amounts in 2021 were primarily due to $41.2 million non-cash revenue recognized under Chinook’s license agreement with SanReno Therapeutics and a $10.0 million milestone payment earned under the collaboration agreement with Merck.

Expenses –

Research and development expenses for the quarter and year ended December 31, 2022 were $43.0 million and $141.2 million, respectively, compared to $24.9 million and $97.0 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, an increase in licensing and contract research and manufacturing costs, consulting and outside services fees, as well as facilities and other costs to continue the progression of our research and clinical programs.

General and administrative expenses for the quarter and year ended December 31, 2022 were $9.8 million and $36.3 million, respectively, compared to $7.7 million and $31.9 million, respectively, for the same periods in 2021. The increase was primarily due to higher employee-related costs, including stock-based compensation expense, higher consulting and outside services costs to support our operations, and other costs. These increases were partially offset by a decrease in facilities costs.

The change in fair value of contingent consideration and contingent value rights liabilities for the quarter and year ended December 31, 2022 resulted in expenses of $7.3 million and $12.0 million, respectively, compared to expenses of $5.8 million and $27.3 million, respectively, for the same periods in 2021. The increase in these non-cash expenses in the quarter ended December 31, 2022 was primarily due to an increase in the fair value of the contingent value rights liability related to the preferred shares in Sairopa mainly as a result of Sairopa entering into a license agreement with Exelixis in November 2022. The decrease in the year ended December 31, 2022 was primarily due to a higher fair value in 2021 that included the impact of earning a milestone payment under the license agreement with Merck.

Net Loss – Net loss for the quarter ended December 31, 2022 was $62.6 million, or $0.90 per share, compared to net income of $7.5 million, or $0.15 per basic share for the same period in 2021. Net loss for the year ended December 31, 2022 was $187.9 million, or $2.92 per share, compared to $102.9 million, or $2.26 per share for the same period in 2021.

SECOND AMENDMENT TO COLLABORATION AGREEMENT BETWEEN AMGEN AND BEIGENE

On February 26, 2023 Amgen reported the company and BeiGene entered into a Second Amendment to the Collaboration Agreement ("Amendment") (Filing, Amgen, FEB 26, 2023, View Source [SID1234648536]). This Amendment amends that certain Collaboration Agreement, entered into as of October 31, 2019 (as amended from time to time, the "Agreement"), by and between Amgen and BeiGene and, solely with respect to Section 13.6 thereof, BeiGene Parent. Capitalized terms used but not defined herein have the meanings given to them in the Agreement.
RECITALS
WHEREAS, pursuant to the Agreement, Amgen and BeiGene collaborate on the commercialization of certain Products (as defined in the Agreement) in the Collaboration Territory (as defined in the Agreement) and the global development funding and clinical development and commercialization of certain clinical-stage pipeline Products in the Collaboration Territory; and
WHEREAS, the Parties desire to enter into this Amendment, upon the terms and conditions set forth herein.
NOW, THEREFORE, in consideration of the premises and the mutual covenants and agreements contained herein, the Parties, intending to be legally bound hereby, do agree as follows:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

1.Amendment to Section 1.13. Section 1.13 of the Agreement is hereby amended by adding the following language at the end of the existing Section 1.13:
"Amgen Pipeline Product Global Development Costs shall not include Costs incurred by Amgen during the period starting on January 1, 2023 and ending on August 31, 2023 to the extent such Costs are attributable to AMG 510 (also known as sotorasib or LUMAKRAS)."
2.Amendment to Section 1.28. Section 1.28 of the Agreement is hereby amended by adding the following language at the end of the existing Section 1.28:
"BeiGene Pipeline Product Development Costs shall not include Costs incurred by BeiGene during the period starting on January 1, 2023 and ending on August 31, 2023 to the extent such Costs are attributable to AMG 510 (also known as sotorasib or LUMAKRAS)."
3.New Section 1.174. The following is hereby inserted as a new Section 1.174 of the Agreement:
"Section 1.174 "Tianjin" means the Pilot Zone in the Tianjin province."
4.New Section 1.175. The following is hereby inserted as a new Section 1.175 of the Agreement:
"Section 1.175 "Tianjin Support Costs" means all actual and, if reasonably practicable, [*]
5.Amendment to Section 5.1.4. Section 5.1.4 of the Agreement is hereby amended and restated in its entirety as follows:
"Section 5.1.4 Reversion of In-Line Products and Pipeline Products. In order to memorialize and effectuate the reversion of Product rights to Amgen pursuant to Sections 5.1.2 and 5.1.3 and Sections 14.6 and 14.9, the Parties shall, within forty-five (45) months following the Effective Date, enter into, execute and deliver a Master Reverse Transition Services Agreement with Product-specific addendums to be entered into at least twenty-four (24) months prior to the expected Product Reversion date (each a "Reverse Transition Services Agreement"), consistent with the scope of the Product Reversion Transition Services Schedule attached hereto, with such changes, if any, as may be mutually agreed by the Parties, including any changes to the Product Reversion Transition Services Schedule as each Party, using its reasonable best efforts, shall negotiate and supplement or finalize. The Parties shall begin good faith negotiations regarding each Reverse Transition Services Agreement at least thirty (30) months prior to the expected Product Reversion Date for the applicable Product."
6.Amendment to Section 7.2.3(b). Section 7.2.3(b) of the Agreement is hereby amended by adding the following to the end of the existing Section 7.2.3(b):
"The table below sets out the 2022 and 2023 baseline budget for Product Team/Work Package Team strategy FTEs based on the Pipeline Product portfolio as of the Second Amendment Effective Date: [*]
7.Amendment to Section 7.2.3(c). Section 7.2.3(c) of the Agreement is hereby amended and restated in its entirety as follows:
"(c) The Product Team and Work Package Team FTE allocation for Pipeline Products will be adjusted by Amgen [*] based on relevant factors, [*]. Such adjusted allocations shall be reflected in the records of the JSC or other governance committee or team."
8.Amendment to Section 7.2.8. Section 7.2.8 (Hainan Bo Ao Cost-Share Matters) of the Agreement is hereby amended and restated in its entirety as follows:

"Section 7.2.8 Early Access Program Cost-Share Matters. Notwithstanding anything to the contrary in this Agreement, with respect to the AMG 510 (also known as sotorasib or LUMAKRAS) Product (as applicable, the "Bo Ao Product," the "Tianjin Product" or, the "Early Access Product"), the Parties desire to initiate the Profit-sharing arrangement set forth in Section 7.2 prior to applicable Initiation Date, subject to the following terms and conditions:
(a) Commercialization and Related Costs. Prior to the applicable Initiation Date, costs (including Costs for outside services and expenses (e.g., consultants, agency fees, etc.)) for the following activities shall be considered "Commercialization and Related Costs" for purposes of determining "Amgen Costs" or "BeiGene Costs," as applicable:
(i) [*];
(ii) Medical Affairs Activities Costs incurred in connection with Hainan Bo Ao and Tianjin in or for the Collaboration Territory prior to commercialization and during commercialization;
(iii) all Costs incurred by the Parties or their respective Affiliates associated with any recalls of the Early Access Product in the Collaboration Scope and in or for the Collaboration Territory;
(iv) all Costs incurred by the Parties or their respective Affiliates with respect to product liability claims for the Early Access Product in the Collaboration Scope in the Collaboration Territory;
(v) all Costs incurred by the Parties or their respective Affiliates associated with any returns and withdrawals of the Early Access Product in the Collaboration Scope in the Collaboration Territory;
(vi) any Third Party IP Payments to the extent not already included in Manufacturing Actual Costs; and
(viii) all unrecovered Indirect taxes, including, for the avoidance of doubt, unrecovered VAT surcharge, incurred by either Party arising with respect to payments to be made under Section 7.2.7 (Calculation of Collaboration Profits).
[*]
Commercialization and Related Costs for purposes of this Section 7.2.8 shall not include [*] or any Cost subject to an indemnification obligation under Article XIII.
(b) Manufacturing Actual Costs. The Manufacturing Actual Costs incurred with respect to the Early Access Product in connection with Hainan Bo Ao or Tianjin, as applicable, shall be deemed "Amgen Costs" for purposes of the calculations set forth under Section 7.2 (Profit Sharing).
(c) Net Revenues. Net Revenues from the sale or transfer for value of the Early Access Product in Hainan Bo Ao or Tianjin, as applicable, shall be considered "Net Revenues" for purpose of Section 7.2 (Profit Sharing).
(d) Support Costs. Bo Ao Support Costs and Tianjin Support Costs incurred with respect to the applicable Early Access Product in connection with Hainan Bo Ao or Tianjin, as

applicable, shall be deemed "Amgen Costs" for purposes of the calculations set forth under Section 7.2 (Profit Sharing)."
9.New Section 7.2.9. The following is hereby inserted as a new Section 7.2.9 of the Agreement:
10.Amendment to Section 7.2. Section 7.2 (Profit Sharing) of the Agreement is hereby amended and restated by adding a new Section 7.2(d):
"Section 7.2.9 Adjustments. Notwithstanding anything to the contrary in this Agreement, within fifty (50) days following December 31, 2023, BeiGene shall deliver to Amgen a statement setting forth, in reasonable detail, [*] (the "Restated Operating Income") [*]. Amgen shall review the calculations delivered by BeiGene and Amgen shall notify BeiGene of any disagreement with the calculations. In the event of a disagreement between the Parties with respect to the Restated Operating Income, the Parties shall cooperate in good faith to resolve such disagreement, and any unresolved disagreements shall be addressed through Section 15.4 of this Agreement. If the agreed-upon Restated Operating Income is a negative number, Amgen shall deliver an invoice to BeiGene setting forth the amount (the "Adjustment Amount") equal to [*] of the absolute value of the Restated Operating Income and BeiGene shall make a payment to Amgen in the amount of the Adjustment Amount, which payment shall be made in accordance with the provisions of Article VIII (Payments)."
11.New Section 11.8. The following is hereby inserted as a new Section 11.8 of the Agreement:
"Section 11.8 Additional Restrictions. With respect to clinical and regulatory information or data belonging to Amgen or a Third Party pertaining to the development of one or more Products in combination with pembrolizumab (such information, the "Amgen Proprietary Information"), the following shall apply:
11.8.1 Designated Personnel.
(a) BeiGene hereby designates the regulatory, clinical, commercial and other personnel (including relevant personnel of its Affiliates and Third Party consultants and contractors) listed on the Designated Personnel Schedule, attached hereto and incorporated herein by this reference, as the designated personnel ("Designated Personnel" and, each, a "Designated Person") to receive Amgen Proprietary Information. Amgen shall ensure storage and use of personal information contained in the Designated Personnel Schedule strictly in observance of and in compliance with Applicable Law on data protection and privacy, consistent with the obligations set out in Section 12.5 (Privacy and Data Protection). BeiGene may, at any time upon written notice to Amgen, revise the Designated Personnel Schedule as reasonably necessary to add Designated Personnel who will be responsible for conducting regulatory activities under the Collaboration Agreement on behalf of BeiGene and to remove Designated Personnel who are no longer responsible for conducting regulatory activities under the Collaboration Agreement on behalf of BeiGene; provided, however, that BeiGene may not disclose any Amgen Proprietary Information to any such new Designated Personnel prior to updating such Designated Personnel Schedule listing such new Designated Personnel and delivering such revised Designated Personnel Schedule to Amgen. BeiGene shall provide Amgen with an updated Designated Personnel Schedule at the end of each semi-annual period ending June 30 and December 31 and at such earlier times as personnel are assigned to receive Amgen Proprietary Information (e.g., upon new employees joining BeiGene in a relevant capacity) and such Designated Personnel Schedule shall cumulatively set out all updates of Designated Personnel Schedule made by BeiGene in such semi-annual period.

(b) BeiGene shall be bound by, and shall ensure that each Designated Person is bound by, restrictions on use and disclosure of any Amgen Proprietary Information it receives consistent with the confidentiality obligations under Article XI (Confidentiality) (including, without limitation, Section 11.1 (Confidentiality; Exceptions)), and BeiGene shall be responsible for each Designated Person’s compliance with such restrictions, as follows:
i.During the Term and for [*] thereafter, each Designated Person (regardless of the date such Designated Person was removed from the list of Designated Personnel) shall keep confidential all Amgen Proprietary Information and shall not publish or otherwise disclose or use for any purpose other than as provided for in this Section 11.8 any Amgen Proprietary Information.
ii.Each Designated Person may use and access such Amgen Proprietary Information solely for the purposes of carrying out the applicable responsibilities of BeiGene under this Agreement, including disclosing such information to the extent reasonably necessary to other Designated Personnel and the relevant Governmental Authority, and, except as permitted under this Section 11.8.1(b)(ii), such Designated Personnel shall not disclose such Amgen Proprietary Information to any other personnel of BeiGene or its Affiliates, including, without limitation, its or their respective Representatives or any Third Party (including any partner or collaborator), for any purpose. For the avoidance of doubt, each Designated Person may not disclose Amgen Proprietary Information to any Third Party Collaboration Personnel (as defined below).
iii.The obligations of nondisclosure and the limitations upon the right to use such Amgen Proprietary Information under this Section 11.8 will not apply to the extent that BeiGene can demonstrate that such Amgen Proprietary Information: (A) was obtained or was already known by BeiGene or its Affiliates without obligation of confidentiality as a result of disclosure from a Third Party that BeiGene did not know, after due inquiry, was under an obligation of confidentiality to Amgen with respect to such information, (B) was generally available to the public or otherwise part of the public domain at the time of its disclosure to BeiGene through no act or omission of BeiGene or its Affiliates or Representatives in breach of this Agreement, (C) became generally available to the public or otherwise part of the public domain after its disclosure and other than through any act or omission of BeiGene or its Affiliates or Representatives in breach of this Agreement or (D) was independently discovered or developed by BeiGene or its Affiliates (without reference to or use of Amgen Proprietary Information or Confidential Information of Amgen).
11.8.2 Third Party Collaborations.
(a) BeiGene agrees that individuals that will receive information from and engage with [*] or any of its Affiliates pursuant to [*], by and between BeiGene and [*], with respect to any proposed and/or approved [*] (as defined in the [*] Agreement) involving a proprietary product that would be a Distracting Product under this Agreement if developed by BeiGene (such individuals, the "Third Party Collaboration Personnel" and, each, a "Third Party Collaboration Person", and such [*], a "Restricted Study") shall not have access to any Amgen Proprietary Information or Confidential Information of Amgen without Amgen’s prior written consent. In no event shall any individual that is or has been a Designated Person or any BeiGene personnel that

have had access to Amgen proprietary clinical, regulatory, and strategic information or data pertaining to Amgen’s global development and commercialization of the Products be classified as a Third Party Collaboration Person.
(b) BeiGene shall not provide any input, advice, feedback, comments, or guidance to [*] or its Affiliates in connection with any Restricted Study; provided, however, that the foregoing shall not restrict the Third Party Collaboration Personnel’s ability to provide comments to a proposed protocol for a Restricted Study to the extent such comments relate solely to patient safety.
11.8.3 Compliance with Section 11.8.
(a) On or before January 15 and July 15 of each calendar year, BeiGene will certify its compliance with the terms of this Section 11.8, including, but not limited to, confirmation that each Designated Person has been made aware of the requirements and restrictions applicable to such Designated Person under this Agreement and that the Designated Personnel Schedule attached hereto are accurate as of such certification date, by providing written confirmation to Amgen in a form acceptable to Amgen.
(b) Upon the written request and reasonable notice of Amgen and not more than once in each calendar year, Amgen shall have the right, at its own expense, to have access (directly or through a Third Party consultant) during normal business hours to records and related systems that are reasonably necessary to assess BeiGene’ compliance with this Section 11.8 to review such records and related systems of BeiGene and any relevant Affiliates solely for the purpose of assessing BeiGene’s compliance with the terms of this Section 11.8."
12.Amendment to Section 12.5: Section 12.5 (Privacy and Data Protection) of the Agreement is hereby amended and restated in its entirety as follows:
"12.5 Data Protection and Privacy.
(a) Generally. Each Party agrees that it determines the purpose and means of processing Personal Data, and, as such, each Party is: (i) acting as a "controller" (as defined under the GDPR and other Applicable Law) of such information and shall be responsible for its own "processing" activities and the activities of its "processors" (as defined under GDPR and other Applicable Law), and (ii) shall comply with GDPR and all applicable Data Protection Laws applicable to a controller, which shall include without limitation employing and maintaining appropriate Security to protect such data. "Security" means technological, physical and administrative controls, including, but not limited to, policies, procedures, organizational structures, hardware and software functions, as well as physical security measures, the purpose of which is, in whole or part, to ensure the confidentiality, integrity or availability of Personal Data. For purposes of this Agreement, (1) "Data Protection Laws" means, as in effect from time to time, with respect to the processing of Personal Data, the applicable data privacy laws of the applicable jurisdiction, including without limitation the European Union General Data Protection Regulation (Regulation (EU) 2016/679) ("GDPR"), together with any national implementing laws in any Member State of the European Union or, to the extent applicable, in any other country, as amended, repealed, consolidated or replaced from time to time and all data breach notification and information security laws and regulations specific thereto and (2) "Personal Data" means any information that relates to, describes or is capable of being associated with or linked to an individual, by direct or indirect means, including without limitation classes, categories and other types of information that may identify an individual as specified by Applicable Law.
(b) Data Transfers. If, in connection with this Agreement or the Safety Agreement, either Party is required to transfer or otherwise disclose to the other Party Personal Data that has not been de-identified or anonymized in accordance with applicable Data Protection Laws (e.g., in connection with the Safety Agreement), the Parties agree to comply with the following:

i.In the event of the actual or reasonably suspected unauthorized access, acquisition, alteration, and/or deletion of Personal Data, collected or otherwise processed under this Agreement, resulting from a breach or violation of Security, each Party shall notify the other, in accordance with the Information Security Schedule, of such incident without undue delay (but in no event later than [*] after discovery). In such event, each Party shall be responsible for fulfilling any reporting and notification obligations required under GDPR and other Applicable Law (inclusive of Data Protection Laws) with regard to the data processing operations it carries out.
ii.The Parties hereby incorporate the EU Standard Contractual Clauses necessary to effectuate the compliant transfer of EU/EEA/UK/Swiss Personal Data outside of EU/EEA/UK/Switzerland to any jurisdiction that does not ensure an adequate level of data protection within the meaning of Data Protection Laws, which Clauses are attached hereto as the Schedule titled "Privacy and Data Protection." In addition, the Parties agree to cooperate with each to effectuate the compliant transfer of Personal Data applicable to other jurisdictions, which may include executing additional data transfer agreements.
iii.The Parties shall notify each other without undue delay (but in no event later [*] after receipt) in the event a data subject included in the Data asserts one of his/her rights under GDPR and Applicable Law (inclusive of Data Protection Laws). Any such notifications shall be made in a pseudonymous form using the subject’s trial-specific identification number only. If necessary and appropriate, the Parties shall reasonably cooperate with each other by providing the necessary information to ensure full and effective implementation of the rights of the data subject. Notification required under this Section shall be made as follows:
Amgen: [*]
BeiGene: [*]
iv.To the extent required under GDPR and Applicable Law (inclusive of Data Protection Laws) and upon a Party’s reasonable request, the other Party shall make available to the requesting Party documentation reasonably necessary to demonstrate the other Party’s compliance with its obligations under GDPR and Applicable Law (inclusive of Data Protection Laws) and such Party’s obligations set out in this Agreement."
13.Amendment to Schedule: The Schedule to the Agreement titled "Privacy and Data Protection" is amended and restated in its entirety in the form attached to this Amendment as Exhibit A and is deemed entered into as of the date of this Amendment.
14.Addition of New Schedules.
(a)A new schedule titled "Designated Personnel Schedule" in the form attached to this Amendment as Exhibit B is hereby added to the Agreement.
15.Select Products.
a.The Parties agree that AMG 701 shall be deemed terminated from the Agreement effective as of December 4, 2022.

b.The Parties shall cooperate with one another in good faith to prepare a transition plan by [*] and such other documentation as may be necessary or useful in connection with the anticipated termination of AMG 510 (also known as sotorasib or LUMAKRAS) from the Agreement; provided, however, that if a further amendment to the Agreement is required in connection with such termination, the Parties shall cooperate with one another in good faith to finalize such amendment by June 30, 2023. The Parties anticipate terminating AMG 510 (also known as sotorasib or LUMAKRAS) from the Agreement by [*].
16.Miscellaneous.
(a)Except as specifically amended above, the Agreement shall continue to be in full force and effect.
(b)This Amendment and its effect are subject to and shall be construed and enforced in accordance with the laws of the State of New York, U.S.A.
(c)This Amendment may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts will be deemed an original, will be construed together and will constitute one and the same instrument. Signature pages of this Amendment may be exchanged by facsimile or other electronic means without affecting the validity thereof.

Good news from Binhui | OH2 Injection has been approved by CDE as a breakthrough therapy product

On February 25, 2023, Wuhan Binhui Biotechnology reported its first oncolytic virus candidate drug recombinant human GM-CSF oncolytic herpes simplex virus type II (OH2) injection (Vero cells) was approved by the State Drug Administration (Press release, Binhui Biotechnology, FEB 25, 2023, View Source [SID1234633513]). Approved by the Center for Evaluation (CDE), included in breakthrough therapy varieties.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

01 "High-speed channel" for drug listing

On July 1, 2020, the newly revised "Measures for the Administration of Drug Registration" was officially implemented. In particular, a chapter on accelerated drug market registration procedures was added, and four fast-track drug reviews were established: breakthrough therapy drugs, conditional approval, priority review and approval, and special approval. Channels to encourage innovation and meet urgent clinical needs. The "Breakthrough Therapy Drug Review Work Procedures (Trial)" also clarified: the Center for Drug Evaluation shall communicate and exchange resources for the priority allocation of drugs included in the breakthrough therapy drug program, strengthen guidance and promote drug research and development; applicants that meet the relevant conditions after evaluation , and may also submit a conditional approval application and a priority review application when applying for a drug marketing authorization.

02 Approved gold standard | Outstanding clinical data

The general idea of ​​the breakthrough therapy drug review process is in line with international standards, and it is benchmarked against FDA Fast Track (FastTrack) and Breakthrough Therapy (Breakthrough Therapy). It is suitable for the prevention and treatment of diseases that are seriously life-threatening or seriously affect the quality of life, and there is no effective treatment Methods or innovative drugs or improved new drugs that have sufficient evidence to show that they have obvious clinical advantages compared with existing treatments. Drugs in clinical trials must have obvious clinical advantages and significant improvement in one or more clinically meaningful endpoints before they can apply for the breakthrough therapy drug program.

03 OH2 Injection | The first oncolytic virus breakthrough treatment product

Owning independent intellectual property rights, the industry-leading Binhui Bio-oncolytic virus (oHSV2) immunotherapy platform is the only industry-university-research integrated research platform in China that develops oncolytic virus products in a fully closed loop. OH2 injection, as the first candidate drug developed by the platform, is the first oncolytic virus independently developed in China to obtain FDA orphan drug designation; it is the first national major new drug creation project of oncolytic virus to enter confirmatory phase III clinical research and the first oncolytic virus to be included in a breakthrough therapy category.

Appendix 4D Half-Year Financial Report

On February 25, 2023 Immutep reported its appendix 4D Half-Year Financial Report (Filing, 3 mnth, DEC 31, Immutep, 2022, FEB 25, 2023, View Source [SID1234627760]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Current Reporting Period – Half-year Ended 31 December 2022

Previous Reporting Period – Half-year Ended 31 December 2021

Revenues

— — to —
Other Income

down 9.4 % to 2,582,728
Total revenue and other income

down 9.4 % to 2,582,728
Loss after tax attributable to members

up 26.8 % to (20,623,250 )
Net loss for the period attributable to members

up 26.8 % to (20,623,250 )
The loss after tax for the half-year ended 31 December 2022 of A$20,623,250 was higher compared to A$16,270,213 for the half-year ended 31 December 2021. The increase in loss after tax for the period ended 31 December 2022 was mainly attributable to the following:


an increase in R&D and intellectual property expenses of $4.3m, mainly attributable to increase of $3.8m in manufacturing costs.

The above increases in loss were offset slightly by the following:


corporate expenses decreased by $0.164m this reporting period which was mainly attributable to a decrease in share based payments expense.


increase in interest income by $0.174m due to an increase in interest rates.

Dividends (Distribution) Amount per Security
Franked Amount

per Security

Final dividend n/a n/a
Previous corresponding period n/a n/a
Record date for determining entitlements to the dividend (in the case of a trust, distribution) n/a
Net Tangible Assets per Share (cents)*
As at 31 December 2022 7.58
As at 31 December 2021 11.37

This half-year financial report does not include all the notes of the type normally included in an annual financial report. Accordingly, this report should be read in conjunction with the annual report for the year ended 30 June 2022 and any public announcements made by Immutep Limited during the half-year reporting period in accordance with the continuous disclosure requirements of the Corporations Act 2001.

Immutep Limited is a company limited by shares, incorporated and domiciled in Australia. Its registered office and principal place of business is at Level 33, 264 George Street, Australia Square, SYDNEY, NSW 2000. Its shares are listed on the Australian Securities Exchange (ASX) and NASDAQ Global Market (NASDAQ).

Your directors present their report on the group consisting of Immutep Limited and the entities it controlled at the end of, or during (referred to hereafter as the "Group" or "Immutep" and or the "Company") the half-year ended 31 December 2022.

Directors

The following persons were directors of Immutep during the whole of the half-year and up to the date of this report unless otherwise stated:

Dr Russell Howard

(Non-Executive Chairman)
Mr Pete Meyers

(Non-Executive Director & Deputy Chairman)
Mr Marc Voigt

(Executive Director & Chief Executive Officer)
Ms Lucy Turnbull

(Non-Executive Director)
Dr Frederic Triebel

(Executive Director & Chief Scientific Officer & Chief Medical Officer: appointed as an Executive Director on 13 September 2022)
PRINCIPAL ACTIVITIES

Immutep is a globally active biotechnology company and a leader in the development of LAG-3 related immunotherapeutic products for the treatment of cancer and autoimmune disease. It is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients.

Immutep has more product candidates and programs focused on LAG-3 immune control mechanism than any other drug development company. Its four product candidates in development have different mechanisms of action. Immutep’s lead product candidate is eftilagimod alpha ("efti" or "IMP321"), a soluble LAG-3 fusion protein (LAG-3Ig). It is a first-in-class antigen presenting cell (APC) activator being explored in late-stage cancer trials. Immutep is also developing an agonist of LAG-3 (IMP761) for autoimmune diseases. The Company also has two further LAG-3 products, including antibodies for immune response modulation, being developed by Immutep’s large pharmaceutical partners, and is conducting ongoing research activities for potential new candidates.

Immutep is listed on the Australian Securities Exchange (IMM), and on the NASDAQ (IMMP) in the United States.

REVIEW OF OPERATIONS AND ACTIVITIES

Throughout the half year and prior, Immutep has continued to progress its active trials of efti, building on the consistently compelling data reported across three key cancer indications and supporting the broad therapeutic potential of efti for non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC) and metastatic breast cancer (MBC). Immutep has received US FDA Fast Track designation for two of these indications, 1st line NSCLC and 1st line HNSCC, enabling e.g. expedited review of potential regulatory submissions.

This promising data, coupled with the large market opportunity and high unmet need for more durable and tolerable options for patients, has informed Immutep’s late-stage clinical development strategy for efti which was announced during the period. The Company has determined to focus its late-stage development efforts on 1st line NSCLC in combination with anti-PD-1 therapy. The NSCLC program (see planned late-stage trial in 1st line NSCLC) will be shaped by the maturing data from the Company’s TACTI-002 and INSIGHT-003 trials, along with feedback from regulatory authorities and other stakeholders.

Immutep will also continue to advance its late-stage programs in HNSCC (see TACTI-003 trial) and MBC (see Late-Stage Phase II/III Trial in MBC). It is also actively expanding efti into additional indications and combination therapies, with a new trial in soft tissue sarcoma and a new trial in urothelial cancer announced during the half year. This clinical development strategy strongly positions Immutep, or a potential partner, to fully exploit efti’s broad potential.

Immutep was pleased to appoint its Chief Scientific Officer and Chief Medical Officer, Professor Frédéric Triebel, M.D. Ph.D. as Executive Director on its Board in the half year, recognising his role as driving force in the strategic development of Immutep’s LAG-3 product candidates. Professor Triebel pioneered the recently validated LAG-3 field of immuno-oncology, having discovered the LAG-3 gene in his early career.

Immutep continues to exercise prudent cash management and remains well-funded with a cash balance of $68.38 million as at 31 December 2022. This provides a cash runway to the end of June, 2024.

Clinical Trials with Eftilagimod Alpha – Three Late-Stage Trials in Key Cancer Indications

Planned late-stage trial with Fast Track designation in 1st line NSCLC

Aligned with its strategy to advance the clinical development of efti in three key indications, Immutep progressed preparatory work for its planned late-stage registrational trial evaluating efti in combination with anti-PD-1 for the treatment of 1st line NSCLC. The trial is being designed to obtain sufficient data to support a potential application for regulatory approval for efti in this indication.

A key achievement in this strategy was the grant of Fast Track designation for this combination therapy for treatment of 1st line NSCLC by the United States Food and Drug Administration (US FDA) in October 2022. Fast Track designation offers the Company the potential for expedited development and review by the FDA. The designation was granted based on the encouraging Phase II clinical data in 1L NSCLC from the TACTI-002 all-comer trial (see page TACTI-002 section). It is the second Fast Track designation issued by the FDA for efti (the first is for 1st line HNSCC, see TACTI-003 section). In addition, the INSIGHT-003 study combining efti with anti-PD-1 and chemotherapy will help further inform our next steps in 1st line NSCLC.

Late-stage trial with Fast Track designation in 1st line HNSCC

TACTI-003 – Phase IIb

TACTI-003 is a Phase IIb multicentre, open label, randomised and controlled trial evaluating efti in combination with pembrolizumab for the treatment of 1st line HNSCC. It was granted Fast Track designation for 1st line HNSCC by the US FDA in 2021.

Initial safety data from the first 47 patients in the study was reviewed by the trial’s Independent Data Monitoring Committee (IDMC) in October 2022, with the IDMC recommending the trial continue with no modifications. The IDMC also reviewed initial efficacy data, although this was not the primary focus of the analysis. The recommendation validates Immutep’s strategy to evaluate efti in the 1st line HNSCC setting, following an encouraging Overall Response Rate (ORR) of 29.7% regardless of PD-L1 expression (a predictive biomarker for effective treatment by immune checkpoint inhibitors such as pembrolizumab) and five complete responses (CR) reported in the 2nd line HNSCC setting in TACTI-002.

A Trial in Progress poster on TACTI-003 was presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting 2022 in early November in Boston, US.

Recruitment into the trial is ongoing, with more than 50% of the planned 154 patients enrolled in December 2022 across 25 active trial sites. TACTI-003 is expected to be fully recruited by mid-2023.

Planned Late-Stage Phase II/III Trial in Metastatic Breast Cancer

For the evaluation of efti in MBC, Immutep continued engagement with regulatory authorities throughout the half year, including with the US FDA for its planned late-stage trial. In December 2022, Immutep received a positive outcome from its follow-up Type C meeting with the FDA. The Company and the FDA have agreed to an integrated Phase II/III trial design to help inform a potential Biologics License Application (a request for permission to sell a biologic product in the US).

Based on the encouraging efficacy, favourable safety and learnings from Immutep’s completed Phase IIb trial (AIPAC, which administered efti in conjunction with a standard-of-care chemotherapy on different days and ceased chemotherapy at six months), patients in the new MBC trial will receive efti and paclitaxel chemotherapy on the same day and treatment will continue until disease progression. In addition to HER2–/HR+ metastatic breast cancer, the patient population has also been expanded to include triple-negative breast cancer, an aggressive form of breast cancer with limited treatment options.

Subject to regulatory and ethics committee feedback, the Phase II portion of the trial is expected to begin in 1st quarter of calendar year 2023 with a safety lead in of 6 to 12 patients, followed by up to 58 patients for the randomised Phase II portion of the trial, testing also a higher dose of efti (30 mg vs 90 mg). Depending on the Phase II results, regulatory interactions and Immutep’s resources, the Phase III portion will commence.

TACTI-002 (also designated KEYNOTE-798) – Phase II

TACTI-002 is Immutep’s Phase II trial being conducted in collaboration with Merck & Co. ("MSD"). This all-comer trial in terms of PD-L1 status is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in NSCLC in 1st and 2nd line, and in HNSCC in 2nd line (Parts A, B and C, respectively). The trial is fully recruited (189 patients).

Part A – 1st line NSCLC – Immutep reported compelling new clinical data from 114 1st line NSCLC patients via a prestigious late-breaking abstract oral presentation at the SITC (Free SITC Whitepaper) Annual Meeting in November 2022. Immutep’s abstract was selected as one of just nine to be showcased at the SITC (Free SITC Whitepaper) 2022 press briefing, out of more than 1,500 abstract submissions.

The results showed an ORR of 40.4% in the all-comer PD-L1 trial, meeting the primary endpoint for Part A (1st line NSCLC) of the TACTI-002 trial. The ORR improved across all PD-L1 status groups by central assessment compared with data reported at an earlier cancer conference, ASCO (Free ASCO Whitepaper) 2022. Additionally, the interim median Duration of Response (DoR) of 21.6 months compares favourably to historical controls.

Promising results were also reported in Part A’s secondary endpoint of interim median Progression Free Survival (PFS). Efti in combination with pembrolizumab has received Fast Track designation after achieving an overall PFS of 6.6 months along with 9.3 months in patients with a PD-L1 Tumour Proportion Score (TPS) >1%.

Part B – 2nd line PD-X Refractory NSCLC – In August 2022, Immutep reported positive interim data from patients with 2nd line PD-X-refractory NSCLC at the 2022 World Conference on Lung Cancer (WCLC 2022) in Austria. The median Overall Survival (OS) reported was 9.7 months in the all-comer PD-L1 patient population, and mOS was not yet reached in patients with PD-L1 TPS of >50%. 25% of patients were progression free at the key 6-month mark and 36.5% were alive at 18 months. Importantly, the combination treatment continues to be safe and well-tolerated. It also compares favourably to standard of care chemotherapy-based options. In total 36 patients have been recruited.

Part C 2nd line HNSCC – Encouraging antitumor activity was reported in previous reporting periods, including an ORR of 29.7% and favourable duration and depth of responses, with five Complete Responses and a minimum duration of response extended to more than 9 months across all responding patients. The responses were reported in both high and low PD-L1 expressors. In total 39 patients have been recruited.

Immutep will report updated clinical results from TACTI-002 during calendar year 2023.

Phase II trial in Soft Tissue Sarcoma

During the half year, Immutep announced further expansion of its efti clinical development pipeline into a new cancer setting with a new investigator-initiated Phase II clinical trial. This trial will be conducted in collaboration with the Maria Skłodowska-Curie National Research Institute in Poland and will evaluate efti in combination with pembrolizumab and radiotherapy, prior to surgery, in up to 40 patients with soft tissue sarcoma. The Maria Skłodowska-Curie National Research Institute of Oncology will primarily fund the study with a grant from the Polish government of € 1.5M (~A$2.2M), with Immutep providing efti at no cost.

Preparations are ongoing to commence the trial in H1 of calendar year 2023.

Institute of Clinical Cancer Research (IKF) INSIGHT Clinical Trial Platform

INSIGHT is an investigator-initiated Phase I clinical trial platform investigating efti in different combination treatments. INSIGHT consists of five different arms from strata A to E, with active arms outlined below. The trial is being conducted by the Institute of Clinical Cancer Research (IKF) at Northwest Hospital, Frankfurt, Germany.

INSIGHT-003 (Stratum C) – Phase I triple combination with standard-of-care anti-PD-1 therapy and chemotherapy

First interim data from the INSIGHT-003 clinical trial was reported in a poster presentation at the SITC (Free SITC Whitepaper) Annual Meeting 2022 in November 2022. The data included initial efficacy results from the 11 of the 14 patients with metastatic NSCLC adenocarcinomas, along with safety data on all 14 patients. The data shows the triple combination approach is well-tolerated and provides promising early signals of therapeutic activity with an ORR of 72.7% (8/11) and a Disease Control Rate (DCR) of 90.9% (10/11). The trial reached its enrolment target of 20 patients with 1L NSCLC following the close of the period, in February 2023.

INSIGHT-005 (Stratum E) – New Phase I trial with Merck KGaA, Darmstadt, Germany, and Pfizer

Immutep entered into a new Clinical Trial Collaboration and Supply Agreement with large pharma partners, Merck KGaA, Darmstadt, Germany and Pfizer, during the half year. It is the second agreement Immutep has signed with Merck KGaA and Pfizer and builds on the encouraging clinical data reported from the completed INSIGHT-004 study of efti and avelumab (BAVENCIO) in multiple solid tumour indications.

The collaboration enables a new Phase I clinical study of efti and avelumab in patients with urothelial cancer that will be conducted under the INSIGHT platform. Under the Agreement, Immutep and Merck KGaA will jointly fund the study, which is expected to start in mid-2023.

EOC Pharma – Phase II (China)

Immutep’s Chinese development partner for efti, EOC Pharma, is continuing to progress it’s plans for the development of efti (designated EOC202) in China.

EOC holds the exclusive development and commercialisation rights of efti in China, Hong Kong, Macau and Taiwan. These rights are retained by Immutep in all other territories.

Commercial Scale Achieved in Manufacturing of Efti

Immutep successfully scaled-up the manufacturing process for efti during the half year, with the completion of its first 2,000L manufacturing run by the Company’s manufacturing partner, WuXi Biologics. This large-scale manufacturing capability is a significant achievement and subject to feedback from competent authorities, Immutep plans to introduce the material manufactured into ongoing and future Phase II/III clinical trials.

This represents an important step towards potential commercial production of efti and supports Immutep’s potential registrational trials of efti in multiple indications.

Preclinical Research & Development

IMP761

Immutep continued to progress the preclinical development steps for its autoimmune disease candidate, IMP761, including successfully establishing a GMP-compliant manufacturing process for IMP761. The 200L scale manufacturing process was developed by the Company’s manufacturing partner, Northway Biotech and will provide supply of IMP761 for Investigational New Drug (IND)-enabling studies and clinical trials.

IMP761 is Immutep’s immunosuppressive agonist antibody to LAG-3 which will be tested to treat the causes of autoimmune diseases, such as inflammatory bowel disease, rheumatoid arthritis, and multiple sclerosis, rather than merely treating the symptoms.

Out-licensed Programs

Novartis – Ieramilimab

Novartis is Immutep’s partner for the development of ieramilimab (Novartis code: LAG525), a humanised LAG-3 antagonist antibody derived from Immutep’s IMP701 antibody.

Novartis continues to evaluate ieramilimab in clinical trials in multiple cancer indications in combination with its PD-1 inhibitor, spartalizumab.

GlaxoSmithKline (GSK) – IMP731

GSK is Immutep’s partner for GSK2831781, a LAG-3 depleting antibody derived from Immutep’s IMP731 antibody.

Immutep’s exclusive license with GSK remains in place for GSK2831781 while the pharma company determines their options for this program.

LabCorp

Laboratory Corporation of America Holdings, known as LabCorp (NYSE: LH), is Immutep’s US-based collaboration partner for the development of immuno-oncology products or services, a field of growing importance since the validation of the first LAG-3 product. Immutep was selected by LabCorp for its in-depth LAG-3 expertise and knowledge.

Beyond its initial fees from LabCorp, Immutep may be eligible to receive further revenues from commercial milestones under its Licence and Collaboration Agreement with LabCorp as the collaboration progresses.

Strengthening Intellectual Property

Immutep continued to build its intellectual property portfolio throughout the half year and was granted five new patents for efti and two patents for IMP761 and IMP731.

Eftilagimod Alpha

Two patents, filed as divisional applications, were granted by the Japanese and South Korean Patent Offices, respectively. These patents protect combination preparations comprising efti and a chemotherapy agent which is oxaliplatin, carboplatin, or topotecan. They follow the grant of the Japanese parent patent and corresponding patents in the United States, Europe, China and Australia, as announced in 2019 through 2021.

The Company was granted another patent by the South Korean Patent Office relating to a potency assay for release testing of efti. The assay is used in Immutep’s commercial-scale (2,000L) manufacturing process.

Immutep was also granted another patent by the Japanese Patent Office directed to combined therapeutic preparations comprising efti and an anti-PD-(L)1 antibody, and methods of use in the treatment of cancer and infection. Additionally, the Russian Patent Office granted a similar patent directed to combined therapeutic preparations comprising efti and an anti-PD-(L)1 antibody. These new patents in Japan and Russia build on corresponding patents granted in Australia, Europe, United States and China, as announced in 2018 through 2022.

IMP731

Immutep was granted a new patent by the Chinese Patent Office protecting IMP731 in the territory of mainland China. The patent is co-owned by Immutep with the French Institute of Health and Medical Research (INSERM) and exclusively licensed to GSK, Immutep’s development partner for IMP731.

IMP761

Immutep was granted a new patent by the Japanese Patent Office protecting IMP761, pharmaceutical compositions comprising IMP761, and the use of the compositions in the treatment of T-cell mediated inflammatory and autoimmune diseases. It follows the grant of a similar European patent announced in October 2020.

Financial Performance

During the current half-year reporting period, total revenue and other income decreased from A$2.85 million to A$2.58 million. This was mainly as a result of a decrease of A$400k in grant income which was partly offset by an increase of A$174k in interest income.

Immutep recognised A$1.66 million of grant income of which A$1.17 million was attributable to the Company’s French subsidiary which receives grant from the French Crédit d’Impôt Recherche scheme for expenditure incurred on eligible research and development activities conducted during the reporting period. Approximately A$484k was recognized in the parent entity from the Australian Federal Government’s R&D tax incentive program, which was provided mainly in respect of expenditure incurred on eligible research and development activities conducted in the reporting period for the TACTI-002 and TACTI-003 trials. Total grant income in the current half-year reporting period is A$1.66 million compared to A$2.06 million in the half year ended 31 December 2021.

Interest income increased from A$130K to A$304k in the current half-year reporting period mainly due to the increase in interest rate.

Research and development and intellectual property expenses increased from A$14.63 million in the half-year ended 31 December 2021 to A$18.97 million in the current half-year reporting period. The increase is mainly attributable to an increase of A$3.80 million in manufacturing costs.

Whilst clinical trial costs related to TACTI-002 declined significantly, clinical trial costs relating to TACTI-003 rose substantially.

Corporate administrative expenses for the current half-year reporting period were A$4.13 million compared to A$4.30 million in the previous comparative period. This was mainly as a result of a decrease in share-based payment expenses.

The loss after tax for the half-year ended 31 December 2022 of A$20,623,250 was higher compared to A$16,270,213 for half-year ended 31 December 2021. This increase was mainly attributable to increase in manufacturing activities and clinical trial activities undertaken during the half year period.

In the half-year ended 31 December 2022, the Company recognized a non-cash gain of A$132K from the net change in fair value of warrants, whilst in half-year ended 31 December 2021 a gain of A$185k in the net change in fair value of warrants was recognized.

Outlook

With a clear clinical development strategy for efti based on compelling data from across three key cancers, and an expanding pipeline of trials in new indications such as soft tissue sarcoma, Immutep is strongly positioned to fully exploit efti’s potential.

We look forward to building on the promising clinical results reported with further data from our TACTI-002 trial and our late-stage TACTI-003 study in 1st line HNSCC in calendar year 2023, as well as potentially commencing new late-stage trials in 1st line NSCLC and MBC.

Auditor’s independence declaration

A copy of the auditor’s independence declaration as required under section 307C of the Corporations Act 2001 is set out on page 10. This report is made in accordance with a resolution of directors.

Yours sincerely,

LOGO

Mr Marc Voigt
CEO and Executive Director
Immutep Limited

24 February 2023

Auditor’s Independence Declaration

As lead auditor for the review of lmmutep Limited for the half-year ended 31 December 2022, I declare that to the best of my knowledge and belief, there have been:

(a)
no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the review, and

(b)
no contraventions of any applicable code of professional conduct in relation to the review.

This declaration is in respect of lmmutep Limited and the entities it controlled during the period.

Jason Hayes
Partner Sydney
PricewaterhouseCoopers 24 February 2023

PricewaterhouseCoopers, ABN 52 780 433 757

One International Towers Sydney, Watermans Quay, Barangaroo, GPO BOX 2650, SYDNEY NSW 2001

T: +61 2 8266 0000, F: +61 2 8266 9999, www.pwc.com.au

Level 11, 1PSQ, 169 Macquarie Street, Parramatta NSW 2150, PO Box 1155 Parramatta NSW 2124

T: +61 2 9659 2476, F: +61 2 8266 9999, www.pwc.com.au

Liability limited by a scheme approved under Professional Standards Legislation.

For the Half-year Ended 31 December 2022

31 December 2022 31 December 2021
Note A$ A$
REVENUE


License revenue

— —
OTHER INCOME


Research material sales

24,004 21,408
Grant income

1,661,530 2,061,145
Net gain on foreign exchange

461,609 454,823
Interest income

303,689 129,841
Net gain on fair value movement of warrants

10 131,896 184,528

Total revenue and other income

2,582,728 2,851,745
EXPENSES


Research and development and intellectual property expenses

(18,973,792 ) (14,629,169 )
Corporate administrative expenses

(4,132,794 ) (4,296,580 )
Net change in fair value of convertible note

11 (84,405 ) (188,967 )
Finance costs

(14,987 ) (7,208 )

Loss before income tax

(20,623,250 ) (16,270,179 )

Income tax expense

— (34 )

Loss for the half-year

(20,623,250 ) (16,270,213 )

Other Comprehensive income/ (loss)


Exchange differences on the translation of foreign operations

1,606,274 (497,992 )

Other comprehensive income / (loss) for the half-year, net of income tax

1,606,274 (497,992 )

Total comprehensive loss for the half-year

(19,016,976 ) (16,768,205 )

Loss is attributable to:


Owners of Immutep Limited

(20,623,250 ) (16,270,213 )

Total comprehensive loss is attributable to:


Owners of Immutep Limited

(19,016,976 ) (16,768,205 )

Loss per share for loss attributable to the ordinary equity holders of the company: Cents Cents
Basic and diluted loss per share

(2.36 ) (1.94 )
The above consolidated statement of comprehensive income should be read in conjunction with the accompanying notes.

As at 31 December 2022

31 December 2022 30 June 2022
Note A$ A$
ASSETS


Current assets


Cash and cash equivalents

5 68,375,941 79,995,129
Current receivables

6 4,994,385 8,373,607
Other current assets

7 1,847,188 2,443,004

Total current assets

75,217,514 90,811,740

Non-current assets


Plant and equipment

8 96,009 37,933
Intangibles

9 10,005,435 10,554,070
Right of use assets

176,768 270,147
Other non-current assets

513,578 495,660

Total non-current assets

10,791,790 11,357,810

Total assets

86,009,304 102,169,550

LIABILITIES


Current liabilities


Trade and other payables

7,863,465 5,752,188
Employee benefits

381,548 357,029
Warrant liability

10 — 131,896
Lease liability

136,756 173,377

Total current liabilities

8,381,769 6,414,490

Non-current liabilities


Convertible note liability

11 780,803 1,452,950
Employee benefits

122,385 117,252
Lease liability

35,097 107,492
Deferred tax liability

— —

Total non-current liabilities

938,285 1,677,694

Total liabilities

9,320,054 8,092,184

Net assets

76,689,250 94,077,366

EQUITY


Contributed equity

12 370,334,456 367,407,757
Reserves

13 27,012,228 29,004,818
Accumulated losses

(320,657,434 ) (302,335,209 )

Equity attributable to the owners of Immutep Limited

76,689,250 94,077,366

Total equity

76,689,250 94,077,366

The above consolidated balance sheet should be read in conjunction with the accompanying notes.

For the Half-year Ended 31 December 2022

Issued
Capital
A$ Reserves
A$ Accumulated
Losses
A$ Total
A$
Balance at 1 July 2021

313,422,305 34,491,526 (274,642,220 ) 73,271,611
Loss for the half-year

— — (16,270,213 ) (16,270,213 )
Other comprehensive income

— (497,992 ) — (497,992 )

Total comprehensive income/(loss) for the half-year

— (497,992 ) (16,270,213 ) (16,768,205 )

Transactions with owners in their capacity as owners:


Contribution of equity, net of transaction costs

51,053,411 — — 51,053,411
Employee Share based payments

— 1,323,706 — 1,323,706
Exercise of vested performance rights

872,250 (872,250 ) — —

Balance at 31 December 2021

365,347,966 34,444,990 (290,912,433 ) 108,880,523

Balance at 1 July 2022

367,407,757 29,004,818 (302,335,209 ) 94,077,366
Loss for the half-year

— — (20,623,250 ) (20,623,250 )
Other comprehensive income

— 1,606,274 — 1,606,274

Total comprehensive income/(loss) for the half-year

— 1,606,274 (20,623,250 ) (19,016,976 )

Transactions with owners in their capacity as owners:


Conversion of convertible notes

1,045,011 (2,589,486 ) 2,301,025 756,550
Employee Share based payments

— 872,310 — 872,310
Exercise of vested performance rights

1,881,688 (1,881,688 ) — —

Balance at 31 December 2022

370,334,456 27,012,228 (320,657,434 ) 76,689,250

The above consolidated statement of changes in equity should be read in conjunction with the accompanying notes.

Consolidated Statement of Cash Flows

For the Half-year Ended 31 December 2022

31 December 2022 31 December 2021
Note A$ A$
CASH FLOWS RELATED TO OPERATING ACTIVITIES


Payments to suppliers and employees (inclusive of Goods and Service Tax)

(15,901,129 ) (15,351,734 )
Grant income received

3,655,807 3,373,975
Research material sales received

40,883 69,166
Interest received

302,762 129,961
Payment for interest on leases

(14,748 ) (10,764 )
Advance from customers

— —
Tax paid

— (34 )

NET CASH OUTFLOWS FROM OPERATING ACTIVITIES

(11,916,425 ) (11,789,430 )

CASH FLOWS RELATED TO INVESTING ACTIVITIES*


Payments for plant and equipment

(75,407 ) (4,437 )
Refund of security deposit

16,201 —

NET CASH OUTFLOWS IN INVESTING ACTIVITIES

(59,206 ) (4,437 )

CASH FLOWS RELATED TO FINANCING ACTIVITIES*


Principal elements of lease payments

(114,182 ) (97,420 )
Prepayment of lease obligation

— (25,327 )
Proceeds from issues of shares

— 52,975,330
Share issue transaction costs

— (2,427,155 )

NET CASH INFLOWS FROM FINANCING ACTIVITIES

(114,182 ) 50,425,428

NET INCREASE IN CASH AND CASH EQUIVALENTS

(12,089,813 ) 38,631,561
Effect on exchange rate on cash and cash equivalents

470,625 431,203
Cash and cash equivalents at the beginning of the half-year

79,995,129 60,593,191

CASH AND CASH EQUIVALENTS AT THE END OF THE HALF-YEAR

5 68,375,941 99,655,955

Non-cash investing and financing activities relate to the following:


Fair value movement of convertible notes disclosed in Note 11 to the financial statements.


Fair value movement of US warrant liability disclosed in Note 10 to the financial statements.


Exercise of vested performance rights for no cash consideration disclosed in in Note 12 to the financial statements.

The above consolidated statement of cash flows should be read in conjunction with the accompanying notes.

1. Summary of Significant Accounting Policies

a) Basis of Preparation

The half-year consolidated financial statements is a general purpose financial report for the half-year ended 31 December 2022 has been prepared in accordance with Australian Accounting Standard AASB 134: Interim Financial Reporting, and the Corporations Act 2001.

The half-year report does not include all the notes of the type normally included in an annual financial report and therefore cannot be expected to provide as full an understanding of the financial performance, financial position and financing and investing activities of Immutep as the annual report.

Accordingly, it is recommended that this financial report be read in conjunction with the annual financial report for the year ended 30 June 2022 and any public announcements made by Immutep Limited during the half-year in accordance with continuous disclosure requirements of the Corporations Act 2001.

International Financial Reporting Standards form the basis of Australian Accounting Standards adopted by the AASB. The half-year financial report complies with International Accounting Standards ("IAS") 34 Interim Financial Reporting as issued by the International Accounting Standards Board ("IASB").

The accounting policies adopted are consistent with those of the previous financial year and corresponding half-year reporting period, except for the adoption of new and amended standards as set out below.

New and amended standards adopted by the Group

A number of new or amended standards became applicable for the current reporting period. The group did not have to change its accounting policies or make retrospective adjustments as a result of adopting these standards.

The accounting policies adopted are consistent with those of the previous financial year and corresponding half-year reporting period.

2. Liquidity

The Group has experienced significant recurring operating losses and negative cash flows from operating activities since its inception. As at 31 December 2022, the Group holds cash and cash equivalents of $68,375,941 (30 June 2022: $99,655,955).

In line with the Group’s financial risk management, the directors have carefully assessed the financial and operating implications of the above matters, including the expected cash outflows of ongoing research and development activities of the Group over the next 12 months. Based on this consideration, the directors are of the view there is no material uncertainty, and the Group will be able to pay its debts as and when they fall due for at least 12 months following the date of these financial statements and that it is appropriate for the financial statements to be prepared on a going concern basis.

Monitoring and addressing the ongoing cash requirements of the Group is a key focus of the directors. This involves consideration of future funding initiatives such as potential business development opportunities, capital raising initiatives, and the control of variable spending on research and development activities of the Group.

3. Dividends

The Group resolved not to declare any dividends in the half-year ended 31 December 2022.

4. Segment Reporting

Identification of reportable operating segments

Operating segments are reported in a manner consistent with internal reports which are reviewed and used by Management and the Board of Directors (who are identified as the Chief Operating Decision Makers (‘CODM’)). The Group operates in one operating segment, being Cancer Immunotherapy.

Timing of revenue recognition continues to be for license revenue and other income at point in time except for interest income which is recognised over time.

Operating segment information

31 December 2022 Immunotherapy
A$ Unallocated
A$ Consolidated
A$
Revenue


License revenue

— — —
Other Income


Grant income

1,661,530 — 1,661,530
Interest income

— 303,689 303,689
Research material sales

24,004 — 24,004
Net gain on foreign exchange

— 461,609 461,609
Net gain on fair value movement of warrants

— 131,896 131,896

Total revenue and other income

1,685,534 897,194 2,582,728

Result


Segment result

(21,436,039 ) 812,789 (20,623,250 )

Loss before income tax expense

(21,436,039 ) 812,789 (20,623,250 )

Income tax expense

Loss after income tax expense

(20,623,250 )

Total segment assets

86,009,304 — 86,009,304

Total segment liabilities

9,320,055 — 9,320,055

31 December 2021 Immunotherapy
A$ Unallocated
A$ Consolidated
A$
Revenue


License revenue

— — —
Other Income


Grant income

2,061,145 — 2,061,145
Interest income

— 129,841 129,841
Research material sales

21,408 — 21,408
Net gain on foreign exchange

— 454,823 454,823
Net gain on fair value movement of warrants

— 184,528 184,528

Total revenue and other income

2,082,553 769,192 2,851,745

Result


Segment result

(16,850,404 ) 580,225 (16,270,179 )

Loss before income tax expense

(16,850,404 ) 580,225 (16,270,179 )

Income tax expense

(34 )

Loss after income tax expense

(16,270,213 )

Total segment assets

120,207,148 — 120,207,148

Total segment liabilities

11,326,625 — 11,326,625

5. Cash and cash equivalents

31 December 2022 30 June 2022
A$ A$
Cash on hand

159 74
Cash in bank

68,073,428 79,693,054
Cash on short term deposit

302,354 302,001

68,375,941 79,995,129

The above cash and cash equivalents are held in AUD, USD, and Euro. The interest rates on these deposits range from 0% to 3.1% (30 June 2022—0% to 1.15%).

6. Current Receivables

31 December 2022 30 June 2022
A$ A$
GST and VAT receivables

731,197 2,088,394
Receivable for grant income

4,262,521 6,267,855
Accounts receivables

667 17,358

4,994,385 8,373,607

Due to the short-term nature of these receivables, the carrying value is assumed to be their fair value as at 31 December 2022.

7. Other current assets

31 December 2022 30 June 2022
A$ A$
Prepayments

1,794,530 2,377,901
Security deposit

51,638 65,060
Accrued income

1,020 43

1,847,188 2,443,004

8. Non-current assets – Plant and Equipment


Plant and

Equipment

A$


Computer

A$


Furniture and

fittings

A$


Total

A$

At 1 July 2021


Cost

549,961 98,985 21,552 670,498
Accumulated depreciation

(534,040 ) (76,825 ) (18,742 ) (629,607 )

Net book amount

15,921 22,160 2,810 40,891

Year ended 30 June 2022


Opening net book amount

15,921 22,160 2,810 40,891
Exchange differences

(504 ) (458 ) (54 ) (1,016 )
Additions

2,343 14,671 5,900 22,914
Disposal

— — — —
Depreciation charge

(7,703 ) (14,112 ) (3,041 ) (24,856 )

Closing net book amount

10,057 22,261 5,615 37,933

At 1 July 2022


Cost

535,749 108,827 26,350 670,926
Accumulated depreciation

(525,692 ) (86,566 ) (20,735 ) (632,993 )

Net book amount

10,057 22,261 5,615 37,933
Half-year ended 31 December 2022


Opening net book amount

10,057 22,261 5,615 37,933
Exchange differences

327 676 196 1,199
Additions

57,760 13,538 4,109 75,407
Disposal

— (2,587 ) — (2,587 )
Depreciation charge

(7,715 ) (6,537 ) (1,691 ) (15,943 )

Closing net book amount

60,429 27,351 8,229 96,009

At 31 December 2022


Cost

607,654 124,410 32,323 764,387
Accumulated depreciation

(547,225 ) (97,059 ) (24,094 ) (668,378 )

Net book amount

60,429 27,351 8,229 96,00

9. Non-current assets – intangibles

Patents Intellectual
Property Goodwill Total
A$ A$ A$ A$
At 1 July 2021


Cost

1,915,671 24,880,102 109,962 26,905,735
Accumulated amortisation

(1,915,671 ) (12,142,816 ) — (14,058,487 )

Net book amount

— 12,737,286 109,962 12,847,248

Year ended 30 June 2022


Opening net book amount

— 12,737,286 109,962 12,847,248
Exchange differences

— (478,979 ) — (478,979 )
Amortisation charge

— (1,814,199 ) — (1,814,199 )

Closing net book amount

— 10,444,108 109,962 10,554,070

At 1 July 2022


Cost

1,915,671 23,864,364 109,962 25,889,997
Accumulated amortisation

(1,915,671 ) (13,420,256 ) — (15,335,927 )

Net book amount

— 10,444,108 109,962 10,554,070

Half-year ended 31 December 2022


Opening net book amount

— 10,444,108 109,962 10,554,070
Exchange differences

— 370,617 — 370,617
Amortisation charge

— (919,252 ) — (919,252 )

Closing net book amount

— 9,895,473 109,962 10,005,435

At 31 December 2022


Cost

1,915,671 24,727,057 109,962 26,752,690
Accumulated amortisation

(1,915,671 ) (14,831,584 ) — (16,747,255 )

Net book amount

— 9,895,473 109,962 10,005,435

Amortisation methods and useful lives

The Group amortises intangible assets with a limited useful life using the straight-line method over the following periods:

•  Patents, trademark and licenses 13-21 years

•  Intellectual property assets 13-14 years

10. Current liabilities – US warrants

31 December 2022 30 June 2022
A$ A$
Opening balance

131,896 722,966
Fair value movements

(131,896 ) (591,070 )
Exercising of warrants

— —

Closing Balance

— 131,896

10. Current liabilities – US warrants (continued)

In July 2017, the Group completed its first US capital raise after it entered into a securities purchase agreement with certain accredited investors for the Group to issue American Depositary Shares (ADSs) and Warrants of Immutep for cash consideration totaling A$6,561,765. In this private placement, the Company agreed to issue unregistered warrants to purchase up to 1,973,451 of its ADSs. The warrants were issued with an exercise price of US$2.50 per ADS, are exercisable immediately and will expire on 5 January 2023. The warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. In December 2020, 1,158,981 of these warrants were exercised at US$2.49 each and in June 2021, 188,230 warrants were exercised at US$2.49 each, hence 206,507 of these warrants remained at 31 December 2022. Subsequent to the reporting period, the remaining 206,507 warrants lapsed on 5 January 2023.

In December 2018, the Group completed its second US capital raise after it entered into a securities purchase agreement with certain accredited investors to purchase American Depositary Shares (ADSs) and Warrants of Immutep for cash consideration totaling A$7,328,509. In this private placement, the Group agreed to issue unregistered warrants to purchase up to 2,080,000 of its ADSs. The warrants were issued with an exercise price of US$2.50 per ADS. The Warrants were able to be exercised in whole or in part at any time or times up until the Warrant Expiry Date of 12 February 2022. The warrants did not confer any rights to dividends or a right to participate in a new issue without exercising the warrant. In December 2020, 2,080,000 of these warrants were exercised at US$2.49 each, hence none of these warrants remain as at 31 December 2022.

Both US warrant issues represent a written option to exchange a fixed number of the Group’s own equity instruments for a fixed amount of cash that is denominated in a foreign currency (US dollars) and is thus classified as a derivative financial liability in accordance with AASB 132 – Financial Instruments. The US warrants liability is initially recorded at fair value at issue date and subsequently measured at fair value through profit and loss at each reporting date. Capital raising costs have been allocated proportionately between issued capital and the US warrant issues in accordance with their relative fair values.

The 10 for 1 share consolidation in November 2019 did not change the number of US warrants nor the exercise price of those warrants as the American Depository Receipt (ADR) ratio was also changed from 1 ADS representing 100 shares to 1 ADS representing 10 shares. The effective date of the change was 5 November 2019.

However, under the anti-dilution clause of share purchase agreements, the exercise price was adjusted due to the entitlement offer the Group conducted in August 2019. As a result, the exercise price for the remaining warrants is now US$2.49.

10. Current liabilities – US warrants (continued)

Fair value of warrants

The warrants granted are not traded in an active market and the fair value has thus been estimated by using the Black-Scholes pricing model based on the following assumptions. Key terms of the warrants are included above. The following assumptions were based on observable market conditions that existed at the issue date and at 31 December 2022:

July 2017 warrants

Assumption
At issue date


At 31 December

2022


Rationale

Historic volatility 58.0% 72.3% Based on 12-month historical volatility data for the Company
Exercise price US$2.50 US$2.49 As per subscription agreement
Share price US$2.17 US$1.75 Closing share price on valuation date from external market source
Risk-free interest rate 1.93% 4.02% Based on the US Government securities yields which match the term of the warrant
Dividend yield 0.0% 0.0% Based on the Company’s nil dividend history
Fair value per warrant
US$1.0716

A$1.3962


US$nil

A$nil

Determined using Black-Scholes models with the inputs above
Fair value A$2,755,375 A$nil Fair value of 1,973,251 warrants as at issue date and fair value of 206,507 warrants as at 31 December 2022

*
Exercising price has been adjusted as per anti-dilution clause in the share purchase agreement.

11. Non-Current liabilities – convertible note

31 December 2022 30 June 2022
A$ A$
Convertible note at fair value at beginning of reporting period

1,452,950 2,526,870
Net change in fair value

84,405 324,736
Transfer to contributed equity on conversion of Convertible notes

(461,805 ) (893,379 )
Transfer to accumulated losses on conversion of Convertible notes

(294,747 ) (505,277 )

Convertible note at fair value at end of reporting period

780,803 1,452,950

On 11 May 2015, the Group entered into a subscription agreement with Ridgeback Capital Investments (Ridgeback) to invest in Convertible Notes and Warrants of the Group for cash consideration totaling A$13,750,828, which was subject to shareholder approval at an Extraordinary General Meeting. Shareholder approval was received on 31 July 2015.

11. Non-Current liabilities – convertible note (continued)

The 13,750,828 Convertible Notes issued have a face value of $1.00 per note, mature on 4 August 2025 and accrue interest at a rate of 3% per annum which may also be converted into shares. Conversions may occur during the period (i) at least 3 months after the Issue Date and (ii) at least 15 business days prior to the maturity date into 50 ordinary shares of the Company per note (subject to customary adjustments for rights or bonus issues, off market buybacks, issues at less than current market price, share purchase plan, dividend reinvestment plan at a discount, return of capital or dividend or other adjustment). If a change of control event, delisting event or event of default has occurred, Ridgeback may elect to convert the notes into shares or repayment of principal and interest. The Convertible Notes rank at least equal with all present and future unsubordinated and unsecured debt obligations of the Company and contain customary negative pledges regarding financial indebtedness, dividend payments, related party transaction and others.

Details of the warrants granted together with the convertible note at initial recognition date were as follows:


8,475,995 warrants were granted with an exercise price of A$0.025 per share exercisable on or before 4 August 2025.


371,445,231 warrants were granted with an exercise price of A$0.0237 per share exercisable on or before 4 August 2020.

As a result of the 10 for 1 share consolidation in November 2019, the above cited warrants were restated in accordance with the subscription agreement. The exercise prices were also adjusted for the pro-rata Entitlement Offer in August 2019 under the anti-dilution provisions of the warrant terms.

The warrant expiry dates remained unchanged. The restated terms were as follows:


847,600 warrants with an exercise price of A$0.248 per share


37,144,524 warrants with an exercise price of A$0.235 per share

37,144,524 warrants with an exercise price of A$0.235 per share lapsed unexercised on 4 August 2020. None of the other warrants specified above have been exercised since initial recognition up to 31 December 2022.

All remaining warrants may be settled on a gross or net basis and the number of warrants or exercise price may be adjusted for a pro rata issue of shares, a bonus issue or capital reorganisation. The Warrants do not confer any rights to dividends or a right to participate in a new issue without exercising the warrant.

Fair value of convertible notes

The following assumptions were used to determine the initial fair value of the debt component of the convertible note which were based on market conditions that existed at the grant date:

Assumption
Convertible notes


Rationale

Historic volatility 85.0% Based on the Company’s historical volatility data
Share price A$0.051 Closing market share price on 31 July 2015
Risk free interest rate 2.734% Based on Australian Government securities yields which match the term of the convertible note
Risk adjusted interest rate 15.0% An estimate of the expected interest rate of a similar non-convertible note issued by the company
Dividend yield 0.0% Based on the Company’s nil dividend history

11. Non-Current liabilities – convertible note (continued)

The fair value of the convertible note is allocated between a financial liability for the traditional note component of the convertible note and into equity which represents the conversion feature. The traditional note component of the convertible note was initially recorded at fair value of $4.4m, based on the present value of the contractual cash flows of the note discounted at 15%. The remaining value of the convertible note was allocated to the conversion feature and recognised as equity.

After initial recognition, there were five subsequent conversions of convertible notes in total as follows and of which one conversion happened during the half year ended 31 December 2022:


Conversion of 3,437,707 convertible notes on 18 March 2021 (25%)


Conversion of 3,437,707 convertible notes on 14 May 2021 (25%)


Conversion of 3,437,707 convertible notes on 7 June 2021 (25%)


Conversion of 1,718,853 convertible notes on 14 March 2022 (12.5%)


Conversion of 859,427 convertible notes on 14 October 2022 (6.25%)

859,427 convertible notes (i.e. 6.25% of the initial convertible notes) remain outstanding as at 31 December 2022, each with a face value of A$1.00. The liability component of the convertible note has been measured at fair value as required by AASB 2 – Share-based Payments.


Convertible Note –

Liability

Conversion Feature
– Equity
A$ A$
Fair value at issuance

4,419,531 41,431,774
Accumulated fair value movements

5,950,682 —
Conversion to ordinary shares

(9,589,410 ) (38,842,288 )

Balance at 31 December 2022

780,803 2,589,486

12. Equity – Contributed

31 December 2022 30 June 2022
Note A$ A$
Issued and Paid-Up Capital


Fully paid ordinary shares

12(a) 360,672,502 357,745,803
Options over fully paid ordinary shares

9,661,954 9,661,954

Total Issued Capital

370,334,456 367,407,757

(a) Ordinary shares

31 December 2022 30 June 2022
Note No. A$ No. A$
At the beginning of reporting period

866,239,815 357,745,803 748,152,935 303,760,351
Shares issued during the year

— — 102,769,866 53,440,330
Transaction costs relating to share issues

12(b) — — — (2,386,919 )
Exercise of performance rights – (shares issued during the year)

12(b) 6,908,380 1,881,688 3,200,000 872,250
Conversion of Convertible Notes (shares issued during the period)

12(b) 6,147,431 1,045,011 12,117,014 2,059,791

At reporting date

879,295,626 360,672,502 866,239,815 357,745,803

(b) Shares issued

31 December 2022 details Number of shares
Issue

price

A$


Total

A$

Exercise of performance rights (shares issued during the period)

6,908,380 0.27 1,881,688
Convertible Notes exercised

6,147,431 0.17 1,045,011

13,055,811 2,926,699

30 June 2022 details Number of shares
Issue
price

A$


Total

A$

Shares issued under Securities Purchase Plan

13,799,149 0.52 7,175,557
Share placement July 2021

88,970,717 0.52 46,264,773
Performance rights exercised (transfer from share-based payment reserve)

3,200,000 0.27 872,250
Convertible Notes exercised

12,117,014 0.17 2,059,791

118,086,880 56,372,371

13. Equity – Reserves and accumulated losses

31 December 2022 30 June 2022
$ $
(a) Reserves


Options issued reserve

19,116,205 19,116,205
Conversion feature of convertible note reserve

2,589,486 5,178,972
Foreign currency translation reserve

1,858,279 252,005
Share-based payments reserve

3,448,258 4,457,636

27,012,228 29,004,818

Movements in options issued reserve were as follows:


Opening balance and closing balance

19,116,205 19,116,205

Movements in conversion feature of convertible note reserve


Opening balance

5,178,972 10,357,944
Transfer to accumulated losses on conversion of Convertible Notes

(2,006,280 ) (4,012,560 )
Transfer to contributed equity on conversion of Convertible Notes

(583,206 ) (1,166,412 )

Ending balance

2,589,486 5,178,972

Movements in foreign currency translation reserve were as follows:


Opening balance

252,005 1,174,332
Currency translation differences arising during the half-year

1,606,274 (922,327 )

Ending balance

1,858,279 252,005

Movements in share-based payments reserve were as follows:


Opening balance

4,457,636 3,843,045
Options and performance rights expensed during the half-year

872,310 1,486,841
Exercise of vested performance rights transferred to contributed equity

(1,881,688 ) (872,250 )

Ending balance

3,448,258 4,457,636

(b) Accumulated losses


Movements in accumulated losses were as follows:


Opening balance

(302,335,209 ) (274,642,220 )
Net loss for the half-year

(20,623,250 ) (32,210,826 )
Conversion of Convertible Notes

2,301,025 4,517,837

Ending balance

(320,657,434 ) (302,335,209 )

14. Subsidiaries

The consolidated financial statements incorporate the assets, liabilities, and results of the following subsidiaries:

Name of entity Country of
incorporation Class of
shares
31 December 2022

%


31 December 2021

%

Immutep Australia Pty Ltd

Australia Ordinary 100% 100%
Immutep IP Pty Ltd

Australia Ordinary 100% 100%
Immutep GmbH

Germany Ordinary 100% 100%
Immutep US Inc

USA Ordinary 100% 100%
PRR Middle East FZLLC

UAE Ordinary 100% 100%
Immutep S.A.S

France Ordinary 100% 100%
15. Contingent Liabilities

There were no material contingent liabilities at 31 December 2022.

16. Events Occurring After the Balance Sheet Date

No matter or circumstance has arisen since 31 December 2022 that has significantly affected, or may significantly affect the Group’s operations, the results of those operations or the Group’s state of affairs in future financial years.

17. Fair value measurement of financial instruments

This note provides an update on the judgements and estimates made by the Group in determining the fair values of the financial instruments since the last annual financial report.

(i) Fair value hierarchy

To provide an indication about the reliability of the inputs used in determining fair value, the Group classifies its financial instruments into the three levels prescribed under the accounting standards. An explanation of each level follows underneath the table.

The following table presents the Group’s financial assets and financial liabilities measured and recognised at fair value at 31 December 2022 and 30 June 2022 on a recurring basis:

At 31 December 2022 Level 1 Level 2 Level 3 Total
A$ A$ A$ A$
Liabilities


Convertible note liability

— — 780,803 780,803
Warrant liability

— — — —

Total liabilities

— — 780,803 780,803

At 30 June 2022 Level 1 Level 2 Level 3 Total
A$ A$ A$ A$
Liabilities


Convertible note liability

— — 1,452,950 1,452,950
Warrant liability

— 131,895 — 131,895

Total liabilities

— 131,895 1,452,950 1,584,845

(ii) Valuation techniques used to determine fair values

Level 1:
The fair value of financial instruments trade in active markets (such as publicly traded derivatives, and trading and available-for-sale securities) is based on quoted (unadjusted) market prices at the end of the reporting period. The quoted market price used for financial assets held by the Group is the current bid price. These instruments are included in level 1.

Notes to the Consolidated Financial Statements (continued)

17. Fair value measurement of financial instruments (continued)

Level 2:
The fair value of financial instruments that are not traded in an active market (for example over-the-counter derivatives) is determined using valuation techniques. These valuation techniques maximise the use of observable market data where it is available and rely as little as possible on entity specific estimates. If all significant inputs required to fair value an instrument are observable, the instrument is included in level 2.

Level 3:
If one or more of the significant inputs is not based on observable market data, the instrument is included in level 3. This is the case for unlisted equity securities.

Specific valuation techniques used to value financial instruments include:


The use of quoted market prices or dealer quotes for similar instruments.


The fair value of interest rate swaps is calculated as the present value of the estimated future cash flows based on observable yield curves.


The fair value of forward foreign exchange contracts is determined using forward exchange rates at the balance sheet date


The fair value of the remaining financial instruments is determined using discounted cash flow analysis

(iii) Fair value measurements using valuation techniques


There are no financial instruments as at 31 December 2022 and 30 June 2022 under Level 1.


Level 2 financial instruments consist of warrant liabilities. Refer to Note 10 for details of fair value measurement.


Level 3 financial instruments consist of convertible notes. Refer to Note 11 for details of fair value measurement

(iv) Valuation inputs and relationships to fair value

The following table summarises the quantitative information about the significant inputs used in level 3 fair value measurements:

Description
Fair value

at 31 December 2022

A$

Unobservable inputs Range of inputs
Convertible note

780,803
Face value

Interest rate of note

Risk adjusted interest rate


859,427
3.0

15.0

%

%

(v) Valuation inputs and relationships to fair value

The convertible note was valued using a discounted cashflow model.

Directors’ Declaration

The Directors of the company declare that:

a)
The financial statements and notes, as set out on pages 11 to 27 are in accordance with the Corporations Act 2001, including:

(i)
complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements; and

(ii)
giving a true and fair view of the group’s financial position as at 31 December 2022 and of its performance for the half-year ended on that date.

b)
there are reasonable grounds to believe that Immutep Limited will be able to pay its debts as and when they become due and payable.

This declaration is made in accordance with a resolution of the Board of Directors.

Mr Marc Voigt

CEO and Executive Director

Immutep Limited

24 February 2023

Independent auditor’s review report to the members of lmmutep Limited

Report on the half-year financial report

Conclusion

We have reviewed the half-year financial report of lmmutep Limited (the Company) and the entities it controlled during the half-year (together the Group), which comprises the consolidated balance sheet as at 31 December 2022, the consolidated statement of comprehensive income, consolidated statement of changes in equity and consolidated statement of cash flows for the half-year ended on that date, significant accounting policies and explanatory notes and the directors’ declaration.

Based on our review, which is not an audit, we have not become aware of any matter that makes us believe that the accompanying half-year financial report of lmmutep Limited does not comply with the Corporations Act 2001 including:

1.
giving a true and fair view of the Group’s financial position as at 31 December 2022 and of its performance for the half-year ended on that date

2
complying with Accounting Standard AASB 134 lnterim Financial Reporting and the Corporations Regulations 2001.

Basis for conclusion

We conducted our review in accordance with ASRE 2410 Review of a Financial Report Performed by the lndependent Auditor of the Entity (ASRE 2410). Our responsibilities are further described in the Auditor’s responsibilities for the review of the half-year financial report section of our report.

We are independent of the Group in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional & Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including independence Standards) (the Code) that are relevant to the audit of the annual financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code.

Responsibilities of the directors for the half-year financial report

The directors of the Company are responsible for the preparation of the half-year financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the directors determine is necessary to enable the preparation of the half-year financial report that gives a true and fair view and is free from material misstatement whether due to fraud or error.

PricewaterhouseCoopers, ABN 52 780 433 757

One International Towers Sydney, Watermans Quay, Barangaroo, GPO BOX 2650, SYDNEY NSW 2001

T: +61 2 8266 0000, F: +61 2 8266 9999

Level 11, 1PSQ, 169 Macquarie Street, Parramatta NSW 2150, PO Box 1155 Parramatta NSW 2124

T: +61 2 9659 2476, F: +61 2 8266 9999

Liability limited by a scheme approved under Professional Standards Legislation.

Auditor’s responsibilities for the review of the half-year financial report

Our responsibility is to express a conclusion on the half-year financial report based on our review. ASRE 2410 requires us to conclude whether we have become aware of any matter that makes us believe that the half-year financial report is not in accordance with the Corporations Act 2001 including giving a true and fair view of the Group’s financial position as at 31 December 2022 and of its performance for the half-year ended on that date, and complying with Accounting Standard AASB 134 lnterim Financial Reporting and the Corporations Regulations 2001.

A review of a half-year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant that might be identified in an audit. Accordingly, we do not express an audit opinion